Post-Operative Water Load Following Transsphenoidal Pituitary Surgery

NCT02727686 | Completed

• 1 other identifier: PHX1600103012
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Delayed post-operative hyponatremia occurs in 5-20% of patients following pituitary surgery and typically occurs on post-operative day 5-10.This decline in sodium can occur rapidly and have serious consequences such as altered mental status, seizures, coma, and even death. Despite significant research into patient demographics and risk factors, the investigators have not been able to predict which patients will suffer from delayed post-operative hyponatremia to date. At the Barrow Neurological Institute, physicians currently utilize an outpatient screening protocol to monitor patients' sodium levels after surgery, but this has yet to be effective for reducing readmissions following pituitary surgery. The etiology of delayed post-operative hyponatremia has been linked to water and sodium dysregulation in the post-operative period. It has been shown that post-operative day 1-2 sodium levels are statistically lower in patients who develop delayed hyponatremia, however, the numerical differences are not large enough to guide clinical management. The investigators propose that a water load on post-operative day 1 may expose underlying sodium/water dysregulation in the early post-operative period. This would improve physicians' understanding of the pathophysiology of post-operative hyponatremia, and it may help to serve as a screening tool for these patients in the future.

Conditions

Hyponatremia; Pituitary Adenoma

Keywords

transsphenoidal pituitary surgery

Outcome Measures

Primary Outcomes (4)

• POD1 Response Serum Sodium

  Evaluate patients' responses to water load on the morning of post-operative day 1: serum sodium (normal range 135-145 mmol/L)

  Post-Operative Day 1

• POD1 Response Serum Osmolality

  Evaluate patients' responses to water load on the morning of post-operative day 1: serum osmolality (normal range 275-300 mOsm/kg)

  Post-Operative Day 1

• POD1 Response Urine Output

  Evaluate patients' responses to water load on the morning of post-operative day 1: urine output (normal range \> 0.5 ml/kg/hr)

  Post-Operative Day 1

• POD1 Response Vasopressin

  Evaluate patients' responses to water load on the morning of post-operative day 1: vasopressin level (normal range 0.0 - 6.9 pg/ml)

  Post-Operative Day 1

Secondary Outcomes (1)

• Post-Discharge Response

  Post-Operative Day 2-7

Study Arms (1)

Water Load (WL) Post-Operative Day 1

EXPERIMENTAL

All enrolled subjects passing conditions outlined in Intervention are eligible to be included. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Patient will have 30 minutes to consume WL, or will be excluded.

Other: Water Load (WL) Post-Operative Day 1

Interventions

Water Load (WL) Post-Operative Day 1 OTHER

Patient will have normonatremic 0600 hr sodium level (Serum Sodium = 135 - 145 mmol/L), ability to safely take water by mouth, and cleared to continue by treating surgeon. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Vasopressin level will be determined. Patient will have 30 minutes to consume WL, or will be excluded. Included patients will have data collected as follows: 1 hour - serum sodium, urine output; 2 hour - serum sodium, urine output, vasopressin level; 6 hours - serum sodium, urine output.

Water Load (WL) Post-Operative Day 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Functioning or non-functioning pituitary adenoma
• Sodium level 135-145 prior to surgery

You may not qualify if:

• Enrolled in a separate pituitary research study
• Unable to provide his/her own consent
• Unable to take PO water
• Renal insufficiency
• Require maintenance corticosteroids pre-operatively
• TSH secreting tumor
• Patients who the treating surgeon deems a poor candidate for the water challenge
• Prisoners
• Pregnant women

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• Barrow Brain and Spine: collaborator
• Barrow Neurological Institute: collaborator

Study Sites (1)

Barrow Brain and Spine

Phoenix, Arizona, 85013, United States

Location

Related Publications (9)

• Hussain NS, Piper M, Ludlam WG, Ludlam WH, Fuller CJ, Mayberg MR. Delayed postoperative hyponatremia after transsphenoidal surgery: prevalence and associated factors. J Neurosurg. 2013 Dec;119(6):1453-60. doi: 10.3171/2013.8.JNS13411. Epub 2013 Sep 20.

  PMID: 24053496 BACKGROUND

• Bohl MA, Ahmad S, Jahnke H, Shepherd D, Knecht L, White WL, Little AS. Delayed Hyponatremia Is the Most Common Cause of 30-Day Unplanned Readmission After Transsphenoidal Surgery for Pituitary Tumors. Neurosurgery. 2016 Jan;78(1):84-90. doi: 10.1227/NEU.0000000000001003.

  PMID: 26348011 BACKGROUND

• Olson BR, Gumowski J, Rubino D, Oldfield EH. Pathophysiology of hyponatremia after transsphenoidal pituitary surgery. J Neurosurg. 1997 Oct;87(4):499-507. doi: 10.3171/jns.1997.87.4.0499.

  PMID: 9322839 BACKGROUND

• Kristof RA, Rother M, Neuloh G, Klingmuller D. Incidence, clinical manifestations, and course of water and electrolyte metabolism disturbances following transsphenoidal pituitary adenoma surgery: a prospective observational study. J Neurosurg. 2009 Sep;111(3):555-62. doi: 10.3171/2008.9.JNS08191.

  PMID: 19199508 BACKGROUND

• Taylor SL, Tyrrell JB, Wilson CB. Delayed onset of hyponatremia after transsphenoidal surgery for pituitary adenomas. Neurosurgery. 1995 Oct;37(4):649-53; discussion 653-4. doi: 10.1227/00006123-199510000-00007.

  PMID: 8559292 BACKGROUND

• Chen L, White WL, Spetzler RF, Xu B. A prospective study of nonfunctioning pituitary adenomas: presentation, management, and clinical outcome. J Neurooncol. 2011 Mar;102(1):129-38. doi: 10.1007/s11060-010-0302-x. Epub 2010 Aug 21.

  PMID: 20730474 BACKGROUND

• Zada G, Liu CY, Fishback D, Singer PA, Weiss MH. Recognition and management of delayed hyponatremia following transsphenoidal pituitary surgery. J Neurosurg. 2007 Jan;106(1):66-71. doi: 10.3171/jns.2007.106.1.66.

  PMID: 17236489 BACKGROUND

• Staiger RD, Sarnthein J, Wiesli P, Schmid C, Bernays RL. Prognostic factors for impaired plasma sodium homeostasis after transsphenoidal surgery. Br J Neurosurg. 2013 Feb;27(1):63-8. doi: 10.3109/02688697.2012.714013. Epub 2012 Aug 21.

  PMID: 22905890 BACKGROUND

• Kelly DF, Laws ER Jr, Fossett D. Delayed hyponatremia after transsphenoidal surgery for pituitary adenoma. Report of nine cases. J Neurosurg. 1995 Aug;83(2):363-7. doi: 10.3171/jns.1995.83.2.0363.

  PMID: 7616287 BACKGROUND

MeSH Terms

Conditions

Hyponatremia; Pituitary Neoplasms

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Andrew S Little, MD

  Barrow Brain and Spine, Phoenix AZ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Manager

Study Record Dates

• First Submitted: March 23, 2016
• First Posted: April 5, 2016
• Study Start: March 7, 2016
• Primary Completion: March 1, 2018
• Study Completion: December 13, 2018
• Last Updated: November 25, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)